Jakafi is the first approved treatment for myelofibrosis, a rare bone marrow cancer, but Incyte will also be able to claim efficacy against the symptoms of the disease thanks to data in labeling from a patient-reported outcomes tool.
Incyte Corp. is in the rare position of being able to claim quality of life benefits for its newly approved drug Jakafi (ruxolitinib) for myelofibrosis, a progressive cancer of the bone marrow that forces blood cell creation into other organs, causing enlargement of the spleen and anemia.
While spleen shrinkage was the primary endpoint in pivotal trials, Incyte also measured the effect of the drug on the...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The Belgian Competition Authority has set out guidance on how pharmaceutical companies can share information on combination therapies when seeking their reimbursement.
The new recommendations should not change insurance coverage, but the tone of the meeting frustrated many medical experts, because of the negative comments on the vaccines.
Confusion, inconsistency and strongly held views complicated the CDC's Advisory Committee on Immunization Practices' votes to change vaccine recommendations for the measles, mumps, rubella, varicella vaccine in young children and tabling of a vote on hepatitis B vaccine at birth.
